Ventolin 4mg Tablets

Manufacturer ALLEN & HANBURYS Active Ingredient Albuterol Tablets(al BYOO ter ole) Pronunciation al-BYOO-ter-ole
It is used to open the airways in lung diseases where spasm may cause breathing problems.
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Drug Class
Bronchodilator
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Pharmacologic Class
Selective Beta-2 Adrenergic Agonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Albuterol tablets are a medication used to help open up the airways in your lungs, making it easier to breathe. They are commonly prescribed for conditions like asthma and chronic obstructive pulmonary disease (COPD) to relieve symptoms such as wheezing, shortness of breath, and chest tightness.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food.

Storing and Disposing of Your Medication

Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom. Ensure that all medications are kept in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs in your area.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses. If you use this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor. Do not take more or less than directed.
  • Do not stop taking the medication without consulting your doctor, even if you feel better.
  • Avoid known triggers for your breathing problems (e.g., allergens, smoke, cold air).
  • Maintain good hydration.
  • If you also use an inhaled bronchodilator, ensure you understand the correct technique and timing for both medications.

Dosing & Administration

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Adult Dosing

Standard Dose: 4 mg three or four times daily
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

initialDose: Start with 2 mg three or four times daily for sensitive patients.
maximumDose: Maximum 32 mg per day in divided doses for patients not responding to 4 mg four times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 2-6 years: 0.1 mg/kg three times daily, not to exceed 2 mg three times daily. 6-12 years: 2 mg three or four times daily. May increase to 4 mg three or four times daily if needed.
Adolescent: 12 years and older: 2-4 mg three or four times daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased side effects.
Severe: Consider lower initial doses and careful monitoring due to renal excretion of drug and metabolites.
Dialysis: Not well studied, but likely requires dose adjustment or careful monitoring.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, as metabolism is not primarily hepatic CYP-mediated.

Pharmacology

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Mechanism of Action

Albuterol is a selective beta-2 adrenergic agonist. It acts by stimulating beta-2 adrenergic receptors in the smooth muscle of the bronchial tree, leading to relaxation of bronchial smooth muscle and bronchodilation. This action is mediated by adenyl cyclase, an enzyme that catalyzes the conversion of ATP to cyclic-3',5'-adenosine monophosphate (cAMP). Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of mediator release from mast cells.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50% (oral)
Tmax: 2-3 hours (oral tablet)
FoodEffect: Food may delay Tmax but does not significantly affect bioavailability.

Distribution:

Vd: Approximately 3.1 L/kg
ProteinBinding: 10% (low)
CnssPenetration: Limited

Elimination:

HalfLife: 4-6 hours (oral tablet)
Clearance: Approximately 0.27 L/hr/kg
ExcretionRoute: Renal (primarily as inactive metabolite)
Unchanged: Approximately 20% (oral dose)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes (oral tablet)
PeakEffect: 2-3 hours (oral tablet)
DurationOfAction: 4-6 hours (oral tablet)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of a severe skin reaction (Stevens-Johnson syndrome, erythema multiforme), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Skin reaction that resembles rings
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Chest pain or pressure
Rapid or irregular heartbeat

This medication may cause severe breathing problems, which can be life-threatening. If you experience trouble breathing, worsening breathing, wheezing, or coughing, especially after using an inhaler or liquid for breathing in, seek medical help immediately.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Feeling nervous or excitable
Dizziness or headache
Upset stomach or vomiting
Shakiness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of breathing problems despite taking the medication.
  • Severe chest pain or pressure.
  • Very fast or irregular heartbeat (palpitations).
  • Severe dizziness or fainting.
  • Muscle cramps or weakness (may indicate low potassium).
  • Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing).
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.

This list is not exhaustive, and it is crucial to discuss all your medications and health conditions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any pre-existing conditions

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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Precautions & Cautions

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To ensure safe use, do not exceed the prescribed dose or frequency of this drug, as overdoses have been fatal. If you have concerns or questions, consult your doctor.

If you find that your usual dose is not providing adequate relief, your symptoms are worsening, or you need to use this medication more frequently than prescribed, contact your doctor immediately.

If you have diabetes (high blood sugar), it is essential to closely monitor your blood sugar levels while taking this drug.

Before taking this medication, inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding. Your doctor will discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Exaggeration of common side effects: tachycardia (very fast heart rate), palpitations, tremor, nervousness, headache, dizziness, nausea, vomiting.
  • Severe symptoms: chest pain, hypertension or hypotension, seizures, metabolic acidosis, hypokalemia, cardiac arrest.

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Beta-adrenergic blocking agents (e.g., cardioselective beta-blockers) may be considered in severe cases, but use with extreme caution due to risk of bronchospasm.

Drug Interactions

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Major Interactions

  • Beta-blockers (e.g., Propranolol, Carvedilol): May block the bronchodilatory effect of albuterol and produce severe bronchospasm in asthmatic patients. Avoid concomitant use.
  • Monoamine Oxidase Inhibitors (MAOIs) and Tricyclic Antidepressants (TCAs): May potentiate the cardiovascular effects of albuterol. Use with extreme caution or avoid within 14 days of discontinuing MAOIs/TCAs.
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Moderate Interactions

  • Diuretics (e.g., Furosemide, Hydrochlorothiazide): May exacerbate ECG changes and/or hypokalemia associated with beta-agonists, especially at higher doses.
  • Digoxin: Albuterol may decrease serum digoxin levels. Monitor digoxin levels.
  • Other Sympathomimetics: Concomitant use may potentiate adverse cardiovascular effects. Use with caution.

Monitoring

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Baseline Monitoring

Pulmonary Function Tests (e.g., FEV1)

Rationale: To establish baseline lung function and assess response to therapy.

Timing: Prior to initiation of therapy.

Vital Signs (Heart Rate, Blood Pressure)

Rationale: To establish baseline and monitor for cardiovascular adverse effects.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom Control (e.g., frequency of wheezing, shortness of breath)

Frequency: Regularly, at each follow-up visit.

Target: Improved breathing, reduced frequency of symptoms.

Action Threshold: Worsening symptoms, increased need for rescue medication, or lack of improvement may indicate need for dose adjustment or alternative therapy.

Adverse Effects (e.g., tremor, tachycardia, palpitations, nervousness)

Frequency: Regularly, at each follow-up visit.

Target: Absence or minimal, tolerable side effects.

Action Threshold: Persistent or severe side effects may require dose reduction or discontinuation.

Serum Potassium (especially with high doses or concomitant diuretics)

Frequency: Periodically, as clinically indicated.

Target: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (below 3.5 mEq/L) may require potassium supplementation or dose adjustment.

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Symptom Monitoring

  • Worsening shortness of breath
  • Increased wheezing
  • Chest tightness
  • Increased cough
  • Increased use of rescue inhaler (if applicable)
  • Palpitations or rapid heart rate
  • Tremor or nervousness

Special Patient Groups

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Pregnancy

Albuterol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity based on animal studies, but human data are limited and conflicting. Use only if clearly needed.
Second Trimester: Generally considered safer than first trimester, but still Category C. Monitor for maternal side effects.
Third Trimester: May inhibit uterine contractions and increase risk of maternal and fetal tachycardia. Use with caution, especially close to term.
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Lactation

Albuterol is excreted in human milk. Caution should be exercised when albuterol is administered to a nursing woman. The decision to discontinue nursing or to discontinue the drug should be made taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderately Safe). Monitor the infant for signs of irritability, poor feeding, or tachycardia. The amount transferred is generally low, but individual infant sensitivity varies.
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Pediatric Use

Oral albuterol tablets are approved for use in children 2 years of age and older. Dosing is weight-based for younger children and then age-based. Close monitoring for adverse effects, especially cardiovascular and CNS effects, is important.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sympathomimetic amines, including cardiovascular effects (e.g., tachycardia, palpitations, hypertension) and CNS effects (e.g., nervousness, tremor). Start with lower doses and titrate carefully, monitoring for adverse reactions.

Clinical Information

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Clinical Pearls

  • Oral albuterol tablets have a slower onset and longer duration of action compared to inhaled albuterol, making them more suitable for maintenance therapy rather than acute symptom relief.
  • Patients should be educated on the difference between oral and inhaled albuterol and when to use each.
  • Monitor for hypokalemia, especially in patients on diuretics or high doses of albuterol.
  • Advise patients to report any worsening of breathing or increased need for rescue medication, as this may indicate inadequate disease control.
  • Caution patients about potential for nervousness, tremor, and palpitations, especially when initiating therapy or increasing dose.
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Alternative Therapies

  • Inhaled short-acting beta-agonists (SABAs) like albuterol inhalers (e.g., Ventolin HFA, ProAir HFA, Proventil HFA) for acute relief.
  • Inhaled long-acting beta-agonists (LABAs) like salmeterol or formoterol for maintenance.
  • Inhaled corticosteroids (ICS) for anti-inflammatory control (e.g., fluticasone, budesonide).
  • Long-acting muscarinic antagonists (LAMAs) like tiotropium.
  • Leukotriene receptor antagonists (LTRAs) like montelukast.
  • Theophylline (less common due to narrow therapeutic index).
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.